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TONER study

TONER study: tolerability of adjuvant Nivolumab in Esophageal cancer: a retrospective cohort study - TONER study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58252
Enrollment
150
Registered
2025-06-16
Start date
2025-02-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal or gastroesophageal junction cancer esophageal cancer

Interventions

n.a.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients with a confirmed diagnosis of esophageal or gastroesophageal junction cancer who completed esophageal or gastroesophageal resection and received at least one cycle of adjuvant nivolumab at Erasmus MC, Amsterdam UMC or UMCG between January 1st, 2022 and December 31st, 2023 will be included

Exclusion criteria

Exclusion criteria: Fully treated at another center, incomplete data as a result of partial treatment at another center, registered with objection to use data for studies.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the incidence of grade III-V adverse events according to CTCAE v5.0.

Secondary

MeasureTime frame
Secondary outcomes measures are related to the safety and tolerability of treatment, such as individual adverse events, and their management, as well as the impact of treatment on disease recurrence and survival.

Countries

Netherlands

Contacts

Public ContactJ.J. de Haan

Universitair Medisch Centrum Groningen

j.j.de.haan@umcg.nl050-3612821

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)